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Introduction
This manual provides information specific to the Monarch™ Platform, also known as the
Monarch™ Platform. The operating instructions and feature descriptions herein are
specific to the software versions listed on page iii.
NOTE: Anyone who operates, services, maintains, or is otherwise associated with the
Monarch Platform must read, understand, and be thoroughly familiar with the
information in this manual, and take precautions to protect themselves, their
associates, patients, and the equipment. At each step in the installation, specific
warnings and cautions are given for specific actions.
Auris Health, Inc. reserves the right to revise this publication and to make changes in
content from time to time without obligation on the part of Auris Health, Inc. to provide
notification of such revision or change.
Intended Use/Indications for Use
The Monarch™ Endoscopy Platform (Monarch Platform) and its accessories are
intended to provide bronchoscopic visualization of and access to patient airways for
diagnostic and therapeutic procedures.
Contraindications
Contraindications include but are not limited to:
Patient whose general health or respiratory function or both are compromised to the
point that the patient would not tolerate flexible bronchoscopy.
Absence of a trained bronchoscopist to perform or closely and directly supervise the
procedure, as well as manage complications common to flexible bronchoscopy.
Use of the system in patients with electrically or magnetically activated implanted
medical devices.
Warnings
A thorough understanding of the technical principles, clinical applications, and risks
associated with pulmonary bronchoscopy is necessary before using this device.
Additional warnings are detailed throughout this document to describe actions or
conditions that could result in injury or death.
Adverse Effects
Complications from bronchoscopy are rare and most often minor, but if they occur, may
include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting,
dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or
an allergic reaction to medications. Only rarely do patients experience other more
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